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Arterial Stiffness and Blood Pressure

Load-Dependent Arterial Stiffness to Optimize Blood Pressure Management in Older Veterans (LOADED BP)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares lower and standard blood pressure goals in Veterans over age 60 with high blood pressure. It tests how these goals affect stiff arteries, the blood vessels that carry blood from the heart, and whether genes help explain the differences.

Hypertension is a common and treatable disorder that remains the leading preventable cause of heart disease. Blood pressure treatment relies mainly on upper arm blood pressure readings and ignores blood vessel physiology and underlying individual genetic information. Older Veterans with hypertension are less likely to be treated to goal blood pressure because there are conflicting recommendations for what constitutes "optimal" in older adults. The investigators have developed a novel way to non-invasively assess the components of blood vessel stiffness that is related to blood pressure (load-dependent stiffness). This project will generate new knowledge about how different blood pressure treatment goals (intensive vs standard) impact different components of arterial stiffness and if these differences can be explained through genetic analysis. Results from this project will offer the VA an updated blueprint for personalizing blood pressure care in older adults, ultimately improving cardiovascular health.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be a Veteran over age 60 in VA health care regions VISN 7, 9, or 12. Men and women may join.
  • Have high blood pressure or take up to 4 medicines for high blood pressure.
  • Have a top blood pressure number of 140 mmHg recorded at 2 or more office visits, or average home readings of 135 mmHg.
  • Agree to be assigned by chance to a lower or standard blood pressure goal and have medicines changed under the study plan.
  • Agree to tests that measure artery stiffness and an ultrasound scan of the arteries in your neck.

Who can't join

  • Need a blood pressure medicine outside the study plan, have high blood pressure caused by another condition, or have a standing top blood pressure number below 110 mmHg.
  • Within the past 12 months, have had a heart artery event or procedure, worsening heart failure or a hospital stay for it, atrial fibrillation (an irregular heartbeat), or a procedure for poor blood flow in the limbs.
  • Have a strong medical need for a beta blocker, including certain irregular heartbeats; heart pumping function below 50%; more than moderate narrowing of the aortic heart valve; or any past stroke.
  • Have severe kidney disease (eGFR below 30, a measure of kidney filtering), more than 1 gram of protein in urine per day, or polycystic kidney disease, which causes kidney cysts.
  • Have active cancer, except untreated prostate cancer that has not spread or non-melanoma skin cancer; lung disease causing low blood oxygen; an active disease such as lupus or rheumatoid arthritis; or HIV.
  • Have an illness caused by an infection, a fever above 38°C, or a hospital stay for any reason within the past 4 weeks.
  • Have an arm that is too large or too small for accurate blood pressure readings.
  • Have factors that may make study visits or treatment hard to follow, such as active substance abuse, plans to move outside the study area within 12 months, or a history of missed medicines or clinic visits.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Male and female participants from VA VISN 7, 9, and 12 will be eligible to participate if they are over age 60 years and have a diagnosis of hypertension or take antihypertensive medications (up to 4). * Veterans will require documented SBP readings on 2 or more office visits that are 140 mmHg or average home blood pressure readings 135 mmHg to be eligible for the trial. * Participants must be willing to be randomized to intensive or standard blood pressure treatment and have blood pressure medications adjusted per the study protocol. * They must be willing to undergo tonometric evaluation of arterial stiffness, and carotid artery ultrasound. Exclusion Criteria: * Participants who have an indication for a specific BP lowering medication that is not included in the study protocol or a known secondary cause of hypertension will be excluded. * Patients will be excluded if they have: * a standing SBP \<110 mmHg * past history of a recent CVD event in the past 12 months (i.e., coronary artery disease event/intervention, congestive heart failure exacerbation or heart failure hospitalization, atrial fibrillation, or peripheral arterial disease intervention) * a class I indication for betablocker use including atrial arrhythmias * left-ventricular systolic function \<50%, \>moderate aortic stenosis * history of stroke * chronic kidney disease (eGFR\<30 mL/min/m2) or proteinuria in excess of 1 gram/day or polycystic kidney disease * active cancer (other than untreated, non-metastatic prostate cancer and non-melanoma skin cancer) * hypoxemic pulmonary disease * active rheumatologic or connective tissue diseases (i.e., systemic lupus erythematosus, rheumatoid arthritis, etc.) * human immunodeficiency virus * illness with any infectious etiology or fever \>38°C (i.e., upper respiratory illness, gastrointestinal illness, etc.) * hospitalization for any reason within the prior 4 weeks * Participants will be excluded if arm circumference is too large/small to allow accurate blood pressure recordings * The investigators will also exclude those with factors that may limit adherence to the study interventions or follow-up including active substance abuse, plans to move outside the study catchment areas within 12 months or a history of poor medication adherence or clinic no-shows

Study sites (3)

AL

TN

WI